Principal Digital Quality & Regulatory Assurance Engineer

BioSpace

North Chicago (IL)

On-site

USD 120,000 - 180,000

Full time

12 hours ago

Be an early applicant

Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

Benefits offered by this job

Comprehensive benefits package

Long-term incentive programs

401(k) retirement plan

Job summary

AbbVie is seeking a Principal Quality Engineer – Digital Regulatory Assurance to lead regulatory and quality oversight for IT applications, infrastructure platforms, and technology solutions in a regulated life sciences environment.

The role focuses on modernizing quality processes through automation, data-driven monitoring, dashboards, and AI-enabled solutions that enhance compliance, streamline SLC activities, and strengthen inspection readiness.

Qualifications

Bachelor’s degree with 7+ years or advanced degree with 6+ years or PhD with 2+ years (from the required education).
Experience in CSA, GxP regulatory requirements, and digital quality transformation.
Experience supporting regulatory audits/inspections and implementing quality monitoring solutions.
Strong project management, analytical, and documentation skills, plus ability to coach diverse audiences.
Knowledge of CSA, digital transformation in quality, and contemporary validation practices.
Expert knowledge of GxP regulations.

Responsibilities

Provide regulatory and quality oversight for SLC-relevant applications, infrastructure, and tech solutions to ensure regulatory compliance.
Act as SME on SLC, CSA, validation, infrastructure qualification, risk management, and compliance.
Lead compliance monitoring across portfolios with reviews, validation health assessments, and quality metrics.
Partner with business and tech teams to embed quality and validation requirements in design, deployment, and support.
Provide guidance on validation strategies, risk assessments, deviations, CAPAs, and audit observations.
Lead audit and inspection readiness activities including preparation, evidence reviews, and remediation planning.
Drive CAPA and audit action management with root cause analysis and effective corrective actions.
Stay updated on evolving regulatory requirements and translate them into lifecycle process improvements.
Serve as the primary SQA contact for digital process improvement and AI enablement initiatives.
Manage automation and AI opportunity pipelines, prioritizing adoption to improve quality and compliance.
Develop dashboards, compliance scorecards, and KPI reporting for visibility into compliance health and risks.
Facilitate governance reviews and cross-functional discussions to ensure consistent quality and regulatory practices.
Coach teams on lifecycle execution, CSA principles, validation, and risk management.